Sevelamer Carbonate

Product NDC
69367-423
11-digit product format
693670423
Labeler code
69367
Product ID
69367-423_f63f474a-c262-4d88-bb90-a25425bdd296
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA200959
Marketing category
ANDA
Marketing start
2025-09-23
Substance
SEVELAMER CARBONATE
Active strength
800 mg/1
Pharmacologic classes
Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sevelamer Carbonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEVELAMER CARBONATE800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9YCX42I8IU
Rxcui749206

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5085f16b-f856-182d-a646-425b62d3f565Product name620251118
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-423-27Sevelamer Carbonate270 in 1 BOTTLETABLET, FILM COATED2701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-423-27EA - Each69367-423e00de75d-fc11-4a49-9954-b23b92dd95f712026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN45a955e9-94ac-48db-838c-74934eae245b1
749206sevelamer carbonate 800 MG Oral TabletSCD45a955e9-94ac-48db-838c-74934eae245b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-423-2769367042327270 TABLET, FILM COATED in 1 BOTTLE (69367-423-27) 2025-09-23NoNoHistorical